Drug recall
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the…
FDA recall event 79682 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 79682 |
|---|---|
| Recall numbers | Z-1734-2018, Z-1735-2018, Z-1736-2018, Z-1737-2018, Z-1738-2018, Z-1739-2018 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee., Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee., Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee., Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee., Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee. and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. |
| Initiation date | Mar 28, 2018 |
| Report date | May 16, 2018 |
| Termination date | Mar 29, 2019 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1825034 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: